NCT00002298

Brief Summary

The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

RibavirinAIDS-Related Complex

Interventions

RibavirinDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Acyclovir.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • CDC classification group IV A (ARC).
  • CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years). Positive plasma p24 antigen.
  • Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
  • Splenectomy.
  • Concurrent Medication:
  • Excluded:
  • Isoprinosine.
  • Patients with the following are excluded:
  • Failure to give informed consent.
  • CDC classification group IV A (ARC).
  • CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years).
  • Positive plasma p24 antigen.
  • Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-03